NCT04544267终止3 期
Efficacy, Immunogenicity, and Safety of High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Number of Participants With Laboratory-Confirmed Influenza Illness Caused by Any Influenza Viral Types/Subtypes
研究概览
简要总结
The primary objective of the study was to compare the clinical efficacy of high-dose quadrivalent influenza vaccine (QIV-HD) to standard-dose quadrivalent influenza vaccine (QIV-SD) in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type.
The secondary objectives of the study were:
- To compare QIV-HD to QIV-SD:
- in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type using a more stringent threshold
- in participants 6 months through 35 months of age for the prevention of laboratory-confirmed protocol-defined influenza-like illness caused by viral strains similar to those contained in the vaccine.
- in participants 6 months through 23 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B types.
- To compare hemagglutination inhibition (HAI) immune response of QIV-HD to QIV-SD in participants 6 months through 35 months of age
- To describe the HAI, seroneutralization (SN), and anti-neuraminidase (NA) immune response
- To describe the immune response to revaccination in Season 3 (Northern Hemisphere)
- To describe the safety profile of each vaccine
详细描述
The study was planned to start in the second half of 2020 with the Sentinel Safety Cohort. Following the Sentinel Safety Cohort, the main efficacy cohort was to be conducted during the 2021-2022 Northern Hemisphere influenza season (Season 1), the 2021-2022 Southern Hemisphere influenza season (Season 2), and the 2021-2022-2023 Northern Hemisphere influenza season (Season 3).
Participants received either 1 or 2 doses of the study vaccine depending on whether they were previously influenza vaccinated or previously influenza unvaccinated, respectively.
Study duration per participant was approximately 6 to 7 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A total of 100 participants were in an uncontrolled, open-label sentinel cohort, while all other participants were in an randomized, modified double-blind design. The following measures ensured the integrity of the blinded data for the participants in the randomized, modified double-blind cohort:
- The unblinded qualified study staff member, independent of the safety evaluation and other study evaluations, administered the vaccine
- The Investigators (or delegates) in charge of safety assessment, the study staff who collect the safety data, and the laboratory personnel who analyze the blood samples did not know which product was administered
- The participant / parent / guardian did not know which product was administered. To maintain the blinding of the participant / parent / guardian, the vaccine syringe label was covered with appropriate materials prior to administration.
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
QIV-HD
Experimental
One injection of QIV-HD on Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
干预措施: Quadrivalent influenza vaccine, high-dose (Biological)
QIV-SD
Active Comparator
One injection of QIV-SD on Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.
干预措施: Quadrivalent influenza vaccine, standard dose (Biological)
结局指标
主要结局
Number of Participants With Laboratory-Confirmed Influenza Illness Caused by Any Influenza Viral Types/Subtypes
时间窗: From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days
Laboratory-confirmed influenza was a positive influenza result on either polymerase chain reaction (PCR) or viral culture. An influenza-like illness (ILI) was occurrence of fever concurrently with at least 1 of the following symptoms: cough, wheezing, difficulty breathing, nasal congestion, rhinorrhea, pharyngitis (sore throat), otitis, vomiting, diarrhea, shivering (chills), fatigue (tiredness), headache, or myalgia (muscle aches).
次要结局
- Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive in Participants Aged 6 Through 23 Months for Any Influenza A or B Type(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Any Influenza A or B Type According to Previous Vaccination Status(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine According to Previous Vaccination Status(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Any Influenza A or B Type and Associated With Acute Otitis Media (AOM)(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine and Associated With Acute Otitis Media(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Any Influenza A or B Type and Associated With Acute Lower Respiratory Infection (ALRI)(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine and Associated With Acute Lower Respiratory Infection(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Geometric Mean Titer of Influenza Vaccine Antibodies(Days 0 and 56)
- Number of Participants With Influenza-Like Illness Polymerase Chain Reaction-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza-Like Illness Culture-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza-Like Illness Polymerase Chain Reaction-Confirmed as Positive for Any Influenza A or B Types(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza-Like Illness Culture-Confirmed as Positive for Any Influenza A or B Types(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Any Influenza A or B Types and Associated With Hospitalization(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza-Like Illness Laboratory-Confirmed as Positive for Viral Strains Similar to Those Contained in the Vaccine and Associated With Hospitalization(From 14 days after the first vaccine administration up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 196 days)
- Number of Participants With Influenza Vaccine Antibody Titer >=10 (1/Dilution)(Days 0 and 56)
- Number of Participants With Seroconversion(Days 0 and 56)
- Influenza Vaccine Antibody Titer Ratio(Days 0 and 56)
- Number of Participants With Influenza Vaccine Antibody Titer >=40 (1/Dilution)(Days 0 and 56)
- Influenza Seroneutralization (SN) Antibody Titer(Days 0 and 56)
- Detectable Influenza Seroneutralization Antibody Titer(Days 0 and 56)
- Influenza Seroneutralization Antibody Titer Ratio(Day 56)
- Number of Participants With Influenza Seroneutralization Antibody Titer >=20 (1/Dilution), >=40 (1/Dilution) and >=80 (1/Dilution)(Day 56)
- Number of Participants With Influenza Seroneutralization Antibody Titer >=2 and >=4 Fold-Rise(Day 56)
- Anti-Neuraminidase (Anti-NA) Antibody Titer(Days 0 and 56)
- Anti-Neuraminidase Antibody Titer Ratio(Day 56)
- Number of Participants With Anti-Neuraminidase Antibody Titer >=20 (1/Dilution), >=40 (1/Dilution) and >=80 (1/Dilution)(Day 56)
- Number of Participants With Anti-Neuraminidase Antibody Titer >=2 and >=4 Fold-Rise(Day 56)
- Detectable Anti-Neuraminidase Antibody Titer(Days 0 and 56)
- Number of Participants With Unsolicited Systemic Adverse Events (AEs) After Each Vaccine Dose Administration(Within 30 minutes after each vaccine administration (vaccines administered at Days 0 and 28))
- Number of Participants With Solicited Injection Site Reactions After Each Vaccine Dose Administration(Within 7 days after each vaccine administration (vaccines administered at Days 0 and 28))
- Number of Participants With Solicited Systemic Reactions After Each Vaccine Dose Administration(Within 7 days after each vaccine administration (vaccines administered at Days 0 and 28))
- Number of Participants With Unsolicited Adverse Events After Each Vaccine Dose Administration(Within 28 days after each vaccine administration (vaccines administered at Days 0 and 28))
- Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)(From first dose of study vaccine administration (Day 1) up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 210 days)
研究者
研究点 (10)
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